Real-time monitoring of kidney grafts on hypothermic machine perfusion
Research type
Research Study
Full title
Determining the feasibility of improving the selection criteria for kidneys sourced from marginal donors through biochemical confirmation of tissue viability and organ function by monitoring a combination of glucose, lactate, and creatinine levels.
IRAS ID
276138
Contact name
Vassilios Papalois
Contact email
Sponsor organisation
Accunea Ltd.
Clinicaltrials.gov Identifier
NCT04619732, ClincalTrials.gov registration
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function. This reduces significantly the number of potentially life saving transplants.
We wish to run a small pilot study to see if we can improve the way we choose kidneys for transplantation by measuring how well they filter the blood and how viable is the organ prior to implantation. We think this new method will help transplant surgeons make better decisions about which kidneys to use.
Our study will look at 10 kidneys from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid.
In our study we will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and maybe the vein (draining blood pipe) or urine output to monitor a number of chemicals made by the kidney. We believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted.
Combining these levels with news of how well the patients recover after surgery will let us design a much larger study to get the right level of information to change the way surgeons choose kidneys and keep more for use.
REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/1286
Date of REC Opinion
18 Dec 2020
REC opinion
Favourable Opinion